Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 9-Month, Brain Imaging and Safety and Efficacy Study of Leuco-methylthioninium bis(hydromethanesulfonate) (LMTM) in Subjects with Early Alzheimer’s Disease.

TauRx Therapeutics Ltd0 sites375 target enrollmentJanuary 18, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: TauRx Therapeutics Ltd
Enrollment: 375
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 18, 2019

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

TauRx Therapeutics Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Early AD, encompassing probable AD and mild cognitive impairment due to AD (MCI\-AD) based on 2011 National Institute on Aging (NIA)/ Alzheimer’s Association (AA) criteria
•All cause dementia and probably AD (probably AD)
•In brief, subjects with probable AD dementia must have insidious onset, worsening impairment in at least two cognitive areas (learning and recall, language, executive function, visuospatial skills), sufficient to significantly interfere with work or usual activities, that is not explained by delirium, drugs, major psychiatric disorder, medical illness, cerebrovascular disease, other forms of dementia, or neurological disorder. The accuracy of the diagnosis will be confirmed independently.
•In subjects with MCI\-AD, there should be evidence of concern about a change in cognition, in comparison with the person’s previous level verified by a knowledgeable informant or clinician. There should also be evidence of lower performance in episodic memory than would be expected for the subject’s age and educational background (typically 1 to 1\.5 standard deviations below the mean). Other mild cognitive deficits may also be present, but there must be preservation of independence in functional abilities. Subjects should not meet the criteria for dementia. The cognitive changes must be mild and there must be no evidence of a significant impairment in social or occupational functioning. Impairments must not be explained by delirium, drugs, major psychiatric disorder, medical illness, cerebrovascular disease, other forms of dementia, or neurological disorder.
•2\.Documented PET scan that is positive for amyloid; if most recent PET scan was performed \>3 years prior to Screening and was negative, it may be repeated (subjects are not eligible if their most recent PET scan was performed within the 3 years prior to Screening and was negative)
•3\. MMSE score of 20\-27 (inclusive) at Screening
•4\. Global Clinical Dementia Rating (CDR) score of 0\.5 at Screening (including a score of \> 0 in one of the functional domains: Community Affairs, Home and Hobbies, or Personal Care) (for both probable AD and MCI\-AD)
•5\. Age \< 90 years at Screening
•6\. Females must meet one of the following:
•Surgically sterile (hysterectomy, bilateral salpingectomy / oophorectomy) for at least 6 months minimum

Exclusion Criteria

•1\. Significant central nervous system (CNS) disorder other than probable Alzheimer’s disease or MCI\-AD, e.g., Lewy body dementia, Parkinson’s disease, multiple sclerosis, progressive supranuclear palsy, hydrocephalus, Huntington’s disease, any condition directly or indirectly caused by Transmissible Spongiform Encephalopathy (TSE), CreutzfeldtJakob Disease (CJD), variant Creutzfeldt\-Jakob Disease (vCJD), or new variant Creutzfeldt\-Jakob Disease (nvCJD)
•2\. Significant intracranial focal or vascular pathology seen on brain MRI scan that would, based on the independent reviewer imaging evaluation, lead to a diagnosis other than probable Alzheimer’s disease or MCI\-AD, including but not limited to:
•Large confluent white matter hyperintense lesions (i.e., Fazekas score of 3\)
•Other focal brain lesions judged clinically relevant by the investigator
•Evidence of a prior or current macrohemorrhage
•3\. Clinical evidence or history of any of the following (within specified period prior to Baseline):
•Cerebrovascular accident (2 years)
•Transient ischemic attack (6 months)
•Significant head injury with associated loss of consciousness, skull fracture or persisting cognitive impairment (2 years)
•Other unexplained or recurrent loss of consciousness \=15 minutes (2 years)